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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Issues Final Rule for Records and Reports on Experiences With Animal Drugs

April 1, 2003

The Food and Drug Administration (FDA) has issued a final rule reducing FDA’s requirements for records and reports concerning experiences with approved new animal drugs. The final rule, published in the March 31, 2003, Federal Register, significantly reduces both reporting and record keeping requirements concerning experiences with New Animal Drug Applications (NADA) and Abbreviated NADAs (ANADA), as compared with current regulations, and incorporates many of the industry comments on earlier drafts.

This final rule clearly defines the kinds of information to be maintained and submitted by new animal drug applicants for an NADA or ANADA. It revises the timing and content of certain reports to enhance their usefulness. It provides for the protection of public and animal health, and reduces the record keeping and reporting requirements.

This final rule is effective June 30, 2003.

Additional information about the final rule may be found in the March 31, 2003, Federal Register or by contacting Dr. Glenn Peterson, Center for Veterinary Medicine (HFV-212), FDA, 7500 Standish Place, Rockville, MD 20855, 301-827-0224.


Contact FDA

240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855